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Manager, Contract Manufacturing Organization

Location:Cincinnati, OH
Exempt/Non-Exempt:Exempt
Employment Type:Full Time
Department:Operations
Description:

The Manager, Contract Manufacturing Organization (CMO) will manage all Devicor Medical Products, Inc. relationships with CMOs. Responsible for identifying, qualifying, negotiating, implementing and managing strategic sourcing strategies and relationships with CMOs to support Devicor Medical Products, Inc. business needs. Acts as the technical/commercial partner with all CMOs and as a gatekeeper to optimize Devicor's business interests.

Duties:
  • Maintains the specification(s) and related Design History File (DHF) and Device Master Record (DMR).
  • Upon Design Transfer, takes ownership of DHF and DMR records and ensures they are maintained and updated as required through change control.
  • Manages the Design Transfer Process, including verification and validation testing at the CMO.
  • Acts as gatekeeper in order to control the two way flow of information between the Company and the CMO. 
  • Coordinates and prioritizes all activities at the CMO.
  • Works closely with Corporate Engineering in coordination of required tasks and outputs.
  • Leads and collaborates with cross-functional teams of subject matter experts to achieve business, operations, and quality objectives in addition to performance goals for the contract manufacturing or business partnerships.
  • Manages the operational activities of the CMO ensuring program cost, quality, metrics, delivery and technology objectives are met as well as manage the partner performance to achieve them. 
  • Partners with key stakeholders in the preparation for Requests for Proposals (RFPs), Statements of Work (SOW) and negotiates supply agreements.
  • Negotiates project fees and milestones pertaining to SOWs, and defines responsibilities between Devicor and the CMO.
  • Ensures continuity of supply of finished goods while sustaining long-term mutually beneficial supplier relationships.
  • Supports Quality Assurance in establishing Quality agreements with all CMOs and assuring that specifications are established before projects are initiated
  • Supports and manages the following activities with the CMO:
    • Change control/management
    • Planned deviation control
    • Rework
    • Investigations
    • Leading cost down and secondary engineering projects
    • Managing PPAPs (part approvals)
  • Other duties as assigned. 

 Travel

  • Must be able to travel up to 25% of the time; both domestic and international travel is required
  • Typical work related travel assignments range 1-3 days, and as such overnight, out-of-town stays are required

 Work Environment And Physical Demands

  • Typical office environment - accommodations will be evaluated where needed.    
Qualifications:

Experience

  • Minimum of 6 years' experience in a medical device manufacturing
    or manufacturing environment required.
  • Working knowledge and experience in Lean and Six Sigma methods, ERP and QMS systems, and logistics and procurement processes is required.
  • Strong understanding of FDA and ISO regulations.

Education

  • BS Degree in Engineering or related field required.
  • MA/MS degree or equivalent experience preferred, but not required.

General Skills/Competencies/Specialized
Knowledge

  • Leadership - Communicates a compelling and inspired vision or
    sense of purpose. Rallies support behind the vision. Demonstrates effective leadership and a sustained record of success. Demonstrated strengths in organization development, planning and communication, including managing direct staff to achieve results and improve the capabilities within their organizations. Provides team members with the opportunities for learning and personal career growth. Takes timely action to address performance issues.
  • Motivating Others - Creates motivating environment. Empowers others. Inspires and motivates entire organizations. Assists in building cohesive teams, bringing out the best from peers while fostering teamwork and collaboration.
  • Negotiation/Influence - Ability to persuade others. Builds consensus and gains cooperation from others to obtain information and accomplish goals.
  • Teamwork - Works collaboratively and cooperatively with many teams cross-functionally. Energetic and willingness to work closely with all team members to achieve success.
  • Problem Solving - Uses rigorous logic to solve problems. Probes all sources for answers. Looks beyond the obvious. Enjoys solving tactical and process problems. Applies advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
  • Strategic Agility - Anticipates future trends and consequences. Creates competitive and breakthrough strategies/plans. Sets priorities wisely and knows how to make tough resource allocation decisions. Continuously finds ways to forward strategic initiatives.
  • Entrepreneurial - Serves as an excellent sounding board for new ideas. Enjoys engaging in thought-provoking and challenging business discussions, but appreciates the value in sound business fundamentals and well-constructed business decisions.
  • Communication Skills - Communicates effectively at all levels, both internally and externally, both written and verbal.
  • Customer Focus - Demonstrates acute awareness of and commitment to internal and external customer requirements.
  • Decision Making - Makes timely, sound decisions based on analysis, wisdom, experience and judgment. Utilizes a high degree of creativity and latitude. Relies on extensive experience and good judgment to ensure that customer expectations are met and that business objectives are achieved.
  • Global Resourcefulness - Achieves objectives across varied international conditions. Effectively leverages local skills.
  • Interpersonal Skills - Relates well to others. Builds constructive and effective relationships. Uses diplomacy and tact.
  • Action Oriented - Enjoys working hard and brings energy to challenging situations. Readily seizes opportunities.
  • Business Acumen - Knows what makes businesses successful. Knowledgeable of how strategies and tactics work. Drives continuous improvement in the value delivered to customers, investors and employees. Actively identifies opportunities and emerging trends. Knowledgeable regarding the operations, unique needs, and goals specific to the organization. Strong commercial awareness (i.e., business relationships, cost/performance understanding).

 



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